Generation R Next intervention study

Partly on the basis of findings from Generation R, new insights have been
developed about the health of (future) parents, reproduction and its effect on
the growth and development of the child. Those insights led to the development
of consultation hours in the preconceptional phase where woman planning for
pregnancy receive advice about lifestyle and health before and during
pregnancy.

In line with recent research results, the importance of a healthy weight (BMI:
18.5-25 kg/m2), stopping the use of alcohol/smoking/drugs, supplementing folic
acid and vitamin D, and the importance of a healthy diet (weekly fish, iron and
vitamin C rich food) are discussed. Reducing feelings of stress also appears to
be effective for improving (maternal) health and reducing risk behavior.
Mind-body therapy, a combination of yoga exercises and mindfulness, has proven
to be a popular intervention, especially among pregnant women or women of
childbearing age from various ethnic backgrounds. Small-scale research shows
that this form of therapy is widely accepted among this population and has low
dropout rates. However, the use of these consultation hours and the given
advice regarding lifestyle and health is not yet optimal. This is partly due to
the difficulty of reaching (vulnerable) groups, together with the limited
insight into the relevance of these recommendations within these groups, the
limited scientific support and the demonstrated effectiveness.

For this reason, we will conduct an intervention study aimed at promoting the
health of (future) parents. The concrete goal of this intervention is to
improve the health of (future) parents by optimizing lifestyle in the
preconception period and early pregnancy to improve birth outcomes and
long-term outcomes in mother and child. The Generation R Next intervention
study will be embedded in the available Generation R Next research
infrastructure with data collection in line with Generation R Next
(MEC-2016-589; NL57828.078.16).

We will include (future) parents in a randomized controlled trial. Inclusion is
possible in the preconception period or in the first trimester of pregnancy
(gestational age < 11 weeks). Follow-up will initially be planned up to and
including the child's age of 54 months. The ambition is to follow the parents
and children for a long time.

After randomization, there will be two groups: the intervention group and the
control group. The intervention group will attend three group sessions (online
or physical, depending on the current covid-19 measures) focusing on national
advice for health during preconception and early pregnancy, coping with stress
and adherence to a healthy(er) lifestyle. They also receive advice regarding a
diet with a focus on products with a low glycemic index. Compliance with the
prescribed advice is encouraged via a digital platform. Prior to the
intervention, the intervention and control group will be offered an individual
lifestyle consultation in line with current national advice for preconception
and early pregnancy.

Participation in the study may result in a burden in time because of the time
investment (i.e. filling out large questionnaires) and inconvenience that comes
with the performed measurements, such as with a blood sample. The risks of
venipuncture (invasive) are negligible as it is a standard procedure that will
be performed by trained staff. If participants do not agree with a vaginal
ultrasound, an abdominal ultrasound will be performed.